When used as a cervical intervertebral fusion device, the HONOUR™ devices are indicated for use at one level in the cervical spine, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft and with supplemental fixation systems cleared for use in the cervical spine (e.g., the Blade® Anterior Cervical Plate System).

When used as a lumbar intervertebral fusion device, the HONOUR™ devices are indicated for use at one or two contiguous levels in the lumbar spine, from L2-S1, in skeletally mature patients who have had six months of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft and with supplemental fixation systems cleared for use in the lumbar spine (e.g., the Inertia® Pedicle Screw System).

When used as a vertebral body replacement device, the HONOUR™ devices are indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The device is intended for use with autograft or allograft and with supplemental internal fixation systems cleared for use in the thoracolumbar spine (e.g., the Inertia® Pedicle Screw System).

Device Description

The HONOUR™ Spacer System is a collection of radiolucent cage devices. The basic shape of these implants is a structural column. The superior and inferior surfaces are open with serrations to facilitate implant stability. The implants are available in an assortment of height, length, width and anteroposterior angulation combinations to accommodate a variety of anatomic requirements.

AI/ML Overview

This is a 510(k) premarket notification for a medical device called the "HONOUR™ Spacer System," which is an intervertebral fusion device and vertebral body replacement device. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than on rigorous clinical studies proving direct device performance against acceptance criteria in the way an AI/software device would.

Therefore, many of the typical elements of an AI/software device performance study (like specific acceptance criteria for diagnostic accuracy, sample sizes for test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance) are not applicable or not present in this document.

Instead, the performance data provided relates to mechanical testing of the physical implant and a comparison of its technological characteristics to predicate devices.

Here's the information extracted from the provided text, addressing your points where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Study Endpoint)	Reported Device Performance
Mechanical Testing:
Static Compression (ASTM F2077)	Performed as well as or better than predicate devices.
Dynamic Compression (ASTM F2077)	Performed as well as or better than predicate devices.
Static Torsion (ASTM F2077)	Performed as well as or better than predicate devices.
Dynamic Torsion (ASTM F2077)	Performed as well as or better than predicate devices.
Subsidence Properties:
Subsidence (ASTM F2267)	Performed as well as or better than predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not applicable in the context of a clinical performance study with human data. The "test set" here refers to the physical devices subjected to mechanical testing. The document states "Mechanical testing of the worst case HONOUR spacer was performed." This implies a limited number of devices, possibly just one or a few, representing the most challenging configuration.
Data Provenance: Not applicable for mechanical test data. The tests were performed in a lab setting according to ASTM standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not applicable. Ground truth for mechanical testing is established by conforming to defined ASTM standards and measurements, not by expert consensus on clinical data.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Mechanical test results are objective measurements from laboratory equipment, not subject to human adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging algorithms where human readers' performance is evaluated with and without AI assistance. This submission is for a physical implant.
Effect Size: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Performance: Not applicable. This is a physical medical device, not a software algorithm with standalone performance to evaluate.

7. The Type of Ground Truth Used

Ground Truth Type: For the mechanical testing, the "ground truth" is defined by the objective physical properties and performance characteristics as measured by standardized engineering tests (ASTM F2077 and ASTM F2267). The comparison is against the performance of legally marketed predicate devices.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable.

Summary of Device Performance Study (as described in the 510(k) for this device):

The "study" described in the document is a mechanical performance study of the HONOUR™ Spacer System.

Methodology: Mechanical testing was conducted on the "worst case HONOUR spacer" according to established ASTM standards:
- ASTM F2077 (for static and dynamic compression, and static and dynamic torsion)
- ASTM F2267 (for subsidence properties)
Objective: To demonstrate that the HONOUR™ Spacer System devices perform "as well as or better than the predicate devices."
Conclusion: The mechanical test results supported the claim that the device is "as safe and as effective as the predicates" based on its physical characteristics and performance under simulated load conditions. This is a key component for demonstrating substantial equivalence for physical implants.

Summary

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K120 245 Pop 1

JUN 1 3 2012

510(k) Summary

Date:

2 February 2012

Sponsor:

Nexxt Spine LLC 10100 Lantern Road, Ste 200 Fishers. IN 46037 Phone: 317.436.7801 Facsimile: 317.245.2518

Andy Elsbury, President

888.3060 and 888.3080

MQP and MAX/ODP

Contact Person:

HONOUR™ Spacer System Trade Names:

Device Classification Class II

Spinal vertebral body replacement device; Intervertebral fusion Classification Name: device with bone graft, lumbar/cervical

Requiation:

Device Product Codes:

Device Description:

Intended Use:

When used as a lumbar intervertebral fusion device, the HONOUR™ devices are indicated for use at one or two contiguous levels in the lumbar spine, from L2-S1, in skeletally mature patients who have had six months of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous graft and with supplemental fixation systems cleared for use in the lumbar spine (e.g., the Inertia® Pedicle Screw System).

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spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The device is intended for use with autograft or allograft and with supplemental internal fixation systems cleared for use in the thoracolumbar spine (e.g., the Inertia® Pedicle Screw System).

Materials:

HONOUR™ Spacers are manufactured from polyetheretherketone (Solvay Zeniva® ZA-500 PEEK) per ASTM F2026. Integral marker pins are manufactured from tantalum according to ASTM F560.

Predicate Devices:

Lumbar I/F Cage® (P960025)

AVS PEEK Spacers (K042571, K050624, K061836, K062132, K073470, K082014, K083661 and K093704)

Stealth™ (K091531)

Construx™ (K051246)

Pillar™ PL/TL (K081177)

Technological Characteristics:

The HONOUR™ Spacer System devices possess the same technological characteristics as the predicate devices. These include:

intended use (as described above), .
basic design (hollow structural frame), .
material (polymer or CFRP), and .
sizes (widths, lengths and heights are within the range(s) offered . by the predicate systems).

Therefore the fundamental scientific technology of the HONOUR™ Spacer System devices is the same as previously cleared devices.

Performance Data:

Mechanical testing of the worst case HONOUR spacer was performed according to ASTM F2077 and included static and dynamic compression and static and dynamic torsion. In addition, the subsidence properties were evaluated according to ASTM F2267.

The mechanical test results demonstrate that the HONOUR™ Spacer System devices perform as well as or better than the predicate devices. Hence these devices are as safe and as effective as the predicates.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN 1 3 2012

Nexxt Spine, LLC % Backroads Consulting, Inc. Karen Warden, Ph.D. P.O. Box 566 Chesterland, Ohio 44026

Re: K120345

Trade/Device Name: Honour Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: ODP, MAX, MQP Dated: May 16, 2012 Received: May 18, 2012

Dear Dr. Warden:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act

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Page 2 -Karen Warden, Ph.D.

or any Federal statutes and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Or ic Far 807), abouning (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please rr you attp://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number: K120345

Device Name: HONOUR™ Spacer System

Indications for Use:

When used as a cervical intervertebral fusion device, the HONOUR™ devices are indicated for use at one level in the cervical spine, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft and with supplemental fixation systems cleared for use in the cervical spine (e.g., the Blade® Anterior Cervical Plate System).

Prescription Use X

Over-the-Counter Use_

(Per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Difision of Surgical, Orthopedic, and Restorative Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Page 118

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.